Gavisol 200 ml Oral Suspension

Gavisol 200 ml is indicated for individuals experiencing gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn during pregnancy, and any instances of epigastric and retrosternal discomfort where the underlying cause is gastric reflux.

Antacids

The mode of action of the product is physical and does not depend on absorption into the systemic circulation. Upon ingestion, Gavisol 200 ml rapidly reacts with gastric acid, forming a protective Alginic acid gel raft with a nearly neutral pH. This raft floats on the stomach contents, effectively preventing gastro-esophageal reflux for up to 4 hours. In severe cases, the raft itself may be refluxed into the esophagus, providing a soothing effect rather than the stomach contents.

Adults and children over 12 years: Take 10-20ml after meals and at bedtime.

Elderly: No dosage adjustment is needed for this age group.

Children 6 to 12 years: Take 5-10ml after meals and at bedtime.

Children under 6 years: Not recommended.

For oral administration:
- Adults and children over 12 years: Take 10-20 mL after meals and at bedtime, up to four times a day.
- Children 6 to 12 years: Take 5-10 mL after meals and at bedtime, up to four times a day.
- Children under 6 years: Not recommended.
- Elderly: No dose modifications necessary.
- Hepatic Impairment: No dose modification necessary.
- Renal Insufficiency: Use caution if a highly restricted salt diet is necessary.

A time interval of 2 hours should be observed between taking this medication and the administration of other medicinal products, particularly tetracyclines, digoxin, fluoroquinolones, iron salts, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, bisphosphonates (diphosphonates), and estramustine.

The Gavisol 200 ml should not be used in patients with a known or suspected hypersensitivity to the active ingredients or any of the excipients.

In addition to the intended effects of the medication, certain side effects may occur, including constipation, flatulence, stomach cramps, or belching. If you experience any of these symptoms, please consult a physician. If an excessive dose is taken, you may experience a sensation of swelling. In such cases, it is advisable to seek medical advice.

Pregnancy: Clinical studies involving over 500 pregnant women, along with extensive post-marketing data, have shown no evidence of malformation or fetal/neonatal toxicity from the active substances. This medication can be safely used during pregnancy when clinically necessary.

Breastfeeding: No adverse effects of the active substances have been observed in breastfed newborns/infants of mothers undergoing treatment. This medication is considered safe for use during breastfeeding.

Fertility: Pre-clinical investigations have demonstrated that alginate has no detrimental effects on parental or offspring fertility or reproduction. Clinical data also do not suggest any impact of this medication on human fertility.

If symptoms do not show improvement within 7 days, it is advisable to reassess the clinical condition. Each 10 mL dose contains 141 mg of sodium (equivalent to 6.2 mmol). This information should be considered when prescribing a highly restricted salt diet, especially in cases of congestive cardiac failure and renal impairment. Each 10 mL dose contains 160 mg of calcium carbonate (equivalent to 1.6 mmol). Caution is warranted when treating patients with hypercalcemia, nephrocalcinosis, and recurrent calcium-containing renal calculi.

In the event of over dosage symptomatic treatment should be given. The patient may notice abdominal distension.

Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children. Do not refrigerate or freeze.

Paediatric Use: This medication is not recommended for children under 6 years of age.Geriatric Use: No dose modification is required for this age group.

Antacids

The Gavisol 200 ml operates through a physical mechanism and does not rely on absorption into the systemic circulation. This product combines two antacids, Calcium Carbonate and Sodium Bicarbonate, with Alginate. When ingested, the medication quickly reacts with gastric acid, forming a protective Alginic Acid gel raft with a nearly neutral pH. Studies have demonstrated that this raft interacts with and covers the acid pocket in the stomach, reducing exposure to esophageal acid. The raft effectively floats on the stomach contents, providing up to 4 hours of relief from gastro-esophageal reflux and safeguarding the esophagus from Acid, Pepsin, and Bile.

In more severe cases, the raft itself may be refluxed into the esophagus, providing a soothing effect instead of the stomach contents. Additionally, in vitro evidence suggests that the raft has a secondary function by entrapping bile and pepsin within its structure, offering further protection to the esophagus from these gastric components. Calcium Carbonate neutralizes gastric acid, delivering rapid relief from indigestion and heartburn. This effect is enhanced by the inclusion of Sodium Bicarbonate, which also has a neutralizing effect.